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Multiple Treatments for Pneumonia (REMAP-CAP Trial)

Phase 3

Recruiting

Research Sponsored by MJM Bonten

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

symptoms or signs or both that are consistent with lower respiratory tract infection

Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with symptoms or signs or both that are consistent with lower respiratory tract infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

REMAP-CAP Trial Summary

This trial is looking at different ways to improve the outcome of patients with community-acquired pneumonia who are admitted to the intensive care unit.

Who is the study for?

This trial is for adults in ICU with severe community-acquired pneumonia, needing ventilators or vasopressors within 48 hours of hospital admission. It's also for those admitted with suspected or proven pandemic infection showing lower respiratory symptoms. Excluded are nursing home residents, recent REMAP participants, patients expected to die within 24 hours without full active treatment commitment, imminent discharges, and those hospitalized over 14 days for a pandemic illness.Check my eligibility

What is being tested?

REMAP-CAP evaluates various treatments to improve outcomes in patients with severe pneumonia in the ICU. It includes drugs like Hydroxychloroquine and Sarilumab among others, different ventilation strategies and doses of anticoagulants. The COVID-19 specific sub-platform tests additional interventions against the virus.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to medications, increased bleeding risk from anticoagulants, liver issues from antivirals like Lopinavir/Ritonavir, gastrointestinal disturbances from antibiotics and immune modulators' impact on infection resistance.

REMAP-CAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have symptoms like a cough or trouble breathing.

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I was admitted to the ICU for severe pneumonia within 2 days of coming to the hospital.

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I am an adult hospitalized with a suspected or confirmed pandemic infection.

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My recent scans show new areas of lung infection or damage.

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I am currently receiving medication to help my heart pump more effectively.

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I require a machine to help me breathe.

REMAP-CAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Days alive and not receiving organ support in ICU

Secondary outcome measures

All-cause mortality

Destination at time of hospital discharge

Health-related Quality of life assessment

+8 more

Other outcome measures

Acute kidney injury (KDIGO stage >= 2 acute kidney injury)

Angioedema

Change from baseline AST, ALT and bilirubin

+13 more

REMAP-CAP Trial Design

18Treatment groups

Experimental Treatment

Group I: Vitamin C DomainExperimental Treatment2 Interventions

Patients admitted to participating hospitals with community-acquired pneumonia will be randomised to receive no vitamin C, or vitamin C. Note: this domain is now closed.

Group II: Simvastatin DomainExperimental Treatment2 Interventions

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no simvastatin, or simvastatin. Note: this domain is now closed.

Group III: Mechanical Ventilation DomainExperimental Treatment2 Interventions

Patients with community-acquired pneumonia admitted to participating intensive care units who are intubated and receiving invasive mechanical ventilation will be randomised to protocolised mechanical ventilation strategy, or clinician-preferred mechanical ventilation strategy

Group IV: Macrolide Duration DomainExperimental Treatment2 Interventions

Patients with community-acquired pneumonia admitted to participating intensive care units who have been allocated to a beta-lactam antibiotic intervention in the Antibiotic Domain will be randomised to either a standard course or extended course of macrolide therapy

Group V: Influenza Immune ModulationExperimental Treatment3 Interventions

Patients with community-acquired pneumonia admitted to participating intensive care units with microbiological testing confirmed influenza infection will be randomised to one of three interventions.

Group VI: Influenza Antiviral DomainExperimental Treatment6 Interventions

Patients with community-acquired pneumonia admitted to participating hospitals with microbiological testing confirmed influenza infection will be randomised to one of six interventions.

Group VII: Immunoglobulin DomainExperimental Treatment3 Interventions

Immunosuppressed patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive no immunoglobulin for COVID-19, or to receive high-titre convalescent plasma. Note: an earlier version of this domain was not restricted to immunosuppressed patients.

Group VIII: Endothelial DomainExperimental Treatment2 Interventions

Patients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no endothelial modulator or enteral imatinib.

Group IX: Cysteamine DomainExperimental Treatment2 Interventions

Group X: Corticosteroid DomainExperimental Treatment5 Interventions

Patients with community acquired pneumonia (CAP) admitted to participating hospitals will be randomised to a steroid use strategy. Note: this domain is now closed to patients with suspected or proven COVID-19. It remains open to patients with CAP without COVID-19.

Group XI: COVID-19 Immune Modulation DomainExperimental Treatment5 Interventions

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five interventions. Note: this domain is now closed.

Group XII: COVID-19 Immune Modulation (2) DomainExperimental Treatment3 Interventions

Patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive one of three interventions. Note: this domain is now closed.

Group XIII: COVID-19 Antiviral DomainExperimental Treatment5 Interventions

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to no ivermectin or ivermectin. Note: an earlier version of this domain evaluated lopinavir-ritonavir, hydroxychloroquine, and combination lopinavir-ritonavir and hydroxychloroquine against a 'no antiviral' control. This domain is now closed.

Group XIV: COVID-19 Antiviral (II) DomainExperimental Treatment4 Interventions

Patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to one of up to four interventions.

Group XV: Antiplatelet DomainExperimental Treatment3 Interventions

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no antiplatelet, aspirin, or site-preferred P2Y12 inhibitor. Note: this domain is now closed.

Group XVI: Anticoagulation DomainExperimental Treatment5 Interventions

Patients admitted to participating intensive care units with suspected or microbiological testing confirmed COVID-19 will be randomised to an anticoagulation strategy. Note: A previous version of this domain evaluated local standard venous thromboprophylaxis against therapeutic dose anticoagulation. This domain is now closed.

Group XVII: Antibiotic DomainExperimental Treatment5 Interventions

Patients with community-acquired pneumonia admitted to participating intensive care units and requiring empiric antibiotic therapy will be randomised one of five antibiotic interventions. Note: the ceftaroline + macrolide intervention has been closed to recruitment.

Group XVIII: ACE2 RAS DomainExperimental Treatment4 Interventions

Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five renin-angiotensin system blockade strategies. Note: this domain is now closed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cysteamine

FDA approved

Valsartan

FDA approved

Hydroxychloroquine

2017

Completed Phase 4

~5360

Ritonavir

FDA approved

Clopidogrel

FDA approved

Vitamin C

2017

Completed Phase 4

~18470

Ivermectin

FDA approved

Nirmatrelvir/ritonavir

2023

Completed Phase 1

~40

Aspirin

2014

Completed Phase 4

~55580

Sarilumab

2020

Completed Phase 3

~5980

Remdesivir

2020

Completed Phase 3

~21440

Baloxavir Marboxil

2019

Completed Phase 4

~4720

Anakinra

2016

Completed Phase 4

~2260

Convalescent plasma

2020

Completed Phase 3

~1290

Baricitinib

2017

Completed Phase 3

~9510

Intermediate dose thromboprophylaxis

2020

Completed Phase 4

~180

Interferon beta-1a

FDA approved

Tocilizumab

2012

Completed Phase 4

~1840

Enalapril

FDA approved

Simvastatin

2012

Completed Phase 4

~1270

Ceftriaxone

2019

Completed Phase 4

~5020

Eritoran

2015

Completed Phase 2

~10

Apremilast

2017

Completed Phase 4

~2300

Imatinib

2011

Completed Phase 3

~3940

Piperacillin-tazobactam

2016

Completed Phase 4

~520

Ceftaroline

2011

Completed Phase 4

~1900

Amoxicillin-clavulanate

2016

Completed Phase 4

~2490

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National University Hospital, SingaporeOTHER

485 Previous Clinical Trials

7,345,464 Total Patients Enrolled

1 Trials studying Pneumonia

St. Marianna University School of MedicineOTHER

7 Previous Clinical Trials

2,323 Total Patients Enrolled

National Intensive Care Surveillance MORUUNKNOWN

Media Library

COVID-19 Immune Modulation Domain Clinical Trial Eligibility Overview. Trial Name: NCT02735707 — Phase 3

Pneumonia Research Study Groups: COVID-19 Immune Modulation Domain, Anticoagulation Domain, Influenza Immune Modulation, COVID-19 Antiviral Domain, Immunoglobulin Domain, Endothelial Domain, Cysteamine Domain, Vitamin C Domain, COVID-19 Antiviral (II) Domain, COVID-19 Immune Modulation (2) Domain, ACE2 RAS Domain, Antibiotic Domain, Macrolide Duration Domain, Corticosteroid Domain, Influenza Antiviral Domain, Simvastatin Domain, Antiplatelet Domain, Mechanical Ventilation Domain

Pneumonia Clinical Trial 2023: COVID-19 Immune Modulation Domain Highlights & Side Effects. Trial Name: NCT02735707 — Phase 3

COVID-19 Immune Modulation Domain 2023 Treatment Timeline for Medical Study. Trial Name: NCT02735707 — Phase 3

Pneumonia Patient Testimony for trial: Trial Name: NCT02735707 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the precedent clinical studies for Simvastatin?

"The first recorded clinical trial for simvastatin was at National Institutes of Health Clinical Center in 1995. In the 26 years since, a total of 22193 completed clinical trials have been performed with 868 currently active studies. A large number of these ongoing trials are based out of Pittsburgh, Pennsylvania."

Answered by AI

Are we currently enrolling people in this clinical trial?

"The trial is still looking for patients, with the most recent update on December 3rd, 2021. The first posting was on April 11th, 2016."

Answered by AI

How many test subjects are in this experiment?

"That is correct. The online information available on clinicaltrials.gov indicates that this particular trial is still recruiting patients. This study was first posted on April 11th, 2016 and updated as recently as December 3rd, 2021. There are 43 different locations where this trial is taking place and they are looking for 10,000 total participants."

Answered by AI

For what purposes is Simvastatin most often prescribed?

"Simvastatin is often used to manage synovitis, but it can also help patients dealing with bacterial conjunctivitis, pain, and cysto-urethritis."

Answered by AI

Are there different research facilities within the US conducting this trial?

"The trial has 43 sites in total with 4 of them being the University of Pittsburgh Medical Centre in Pittsburgh, Pennsylvania, William Osler Health System in Brampton, Ontario, and McGill University Health Centre in Montréal, Quebec."

Answered by AI

Has Simvastatin been cleared for public consumption by the FDA?

"Simvastatin has received a safety score of 3. This is because it is a Phase 3 trial, meaning that there is evidence from multiple clinical studies supporting both its efficacy and safety."

Answered by AI